A Double-Blind, Randomized, Parallel Group, Placebo Controlled Study, Evaluating the Decongestant Effect, Time to Onset, Duration of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common Cold

To evaluate the decongestant effect of xylometazoline in subjects with

common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.

Secondary Outcome Measures:

To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction

and duration of relief of nasal obstruction

Estimated Enrollment:

60

Study Start Date:

March 2007

Study Completion Date:

April 2007

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Over 18 years

Have had moderate common cold symptoms for less than 36 hours.

Exclusion Criteria:

Congested/runny nose for more than two continuous weeks in the previous 12 months

Deviated septum or nasal polyps

Recent use of antibiotics

Recent sinusitis

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452270